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1
Vereen, Endia. "Trademark Protection in Bankruptcy Proceedings: A Closer Look at Lubrizol and its Progeny." Pittsburgh Journal of Technology Law and Policy 15, no. 1 (February 10, 2015): 57–76. http://dx.doi.org/10.5195/tlp.2014.156.
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When the worlds of bankruptcy and intellectual property licenses converge, licensees are placed in potentially dangerous positions. The seminal case on this issue, Lubrizol Enterprises, Inc. v. Richmond Metal Finishers, Inc., stands for the proposition that when a licensor rejects an intellectual property license as "executory," the licensee no longer has the right to rely on provisions within the agreement with the debtor for continued use of the technology. To countermand the negative effects of Lubrizol, Congress amended the Bankruptcy Code, but intentionally omitted trademarks from the definition of intellectual property. This omission has produced a string of conflicting case law, leaving trademark licensees in a precarious position with few options for recourse. This Note discusses the Intellectual Property Bankruptcy Protection Act and trademark protection specifically, and details the circuit split created by Sunbeam Products, Inc. v. Chicago American Manufacturing. This Note focuses on the implications of the circuit split, and concludes by providing some suggestions for how courts can resolve this issue in the future.
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Zenker, Ilona. "KNOWLEDGE BEYOND BORDERS." KNOWLEDGE INTERNATIONAL JOURNAL 30, no. 1 (March 20, 2019): 273–75. http://dx.doi.org/10.35120/kij3001273z.
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―Common knowledge‖ refers to information that the average, educated citizen would accept as reliable without checking it up. The ―personal knowledge‖ possessed by any individual, usually accumulated through observation, research or personal experiences. ―Intellectual knowledge‖ is any product of the human intellect that the law protects from unauthorized use by others. Intellectual property is legally protected as patent, copyright or trademark. Knowledge can only skip borders in case of a proper knowledge transfer (KT). KT can be difficult because of different views on explicitness of knowledge, language, geography, generational differences, religions aspects, political influence, competition, economical issues, national and international conflicts, migration, misconceptions, mutual trust, rewards, timeframe, IT capacities, faulty information, motivation issues or communication. Communication can be a boundary. Effective knowledge transfer requires an effective understanding between sender and receiver. Every field of knowledge has its own jargon and special technical terms. To solve ―syntactic boundaries‖, a common lexicon for terms must be developed. Now sender and receiver have to find a common understanding to avoid misinterpretation. Semantic boundaries‖ focus on translating knowledge and to develop common interpretations. ―Pragmatic boundary‖ is the conflict of the different interest for the parties to use knowledge. Knowledge beyond borders has to deal with legal borders, which are national and international regulation and laws. Transferring knowledge without legal protection would lead to unauthorized access or even illegal alteration of knowledge. If a source of knowledge must be afraid to lose control over his intellectual property it could cause a total stop of exchanging of knowledge, especially beyond borders. Therefore protection of intellectual property is the bridge to overcome such borders. Under German law intellectual knowledge is protected by: German Patent Act: A patent is an official right to be the only person or company allowed to make or to sell a new product or a new idea for a certain period of time. A German patent can be obtained through the direct filing of a national patent application with the German Patent and Trade Mark Office, through the filing of a European patent application or through the filing of an international application under the Patent Cooperation Treaty. The German patent has a term of 20 years. German Trademark Act: A trademark is a recognizable sign or design, capable of distinguishing the goods or services of one enterprise from those of other enterprises. A trademark may be established through actual use in the marketplace, or through registration of the mark with the trademarks office. German Copyright Act: Another type of intellectual property is creative works such as paintings, writing, architecture, software, photos, dance and music are protected by the German Copyright Act (Urheberrechtsgesetz). The copyright law protects an author regarding their intellectual and personal relationship to the work and the types of its utilization. A work and the knowledge behind must meet certain minimum criterions to qualify for copyright protection. There a different kinds of copy rights, which are exclusive licences, exploitations rights, non-exclusive and exclusive rights of use. The length of protection also varies depending on when the work was created or first published. The true source of improving human welfare is knowledge without borders. Therefore it is more important than ever to protect the intellectual knowledge to distribute knowledge over national and international borders without harming the source of knowledge, which is at the end the mind of an individual person. As a consequence borders will become bridges.
3
Sujatmiko, Agung. "KETERKAITAN PERJANJIAN LISENSI MERK DENGAN PERJANJIAN WARALABA DAN DISTRIBUSI." Jurnal Hukum & Pembangunan 40, no. 4 (December 3, 2010): 537. http://dx.doi.org/10.21143/jhp.vol40.no4.230.
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AbstrakThe exclusive rights of trademark, consisting of the right to use and tolicense to other people to use the trademark, must be protected. The licensingof trademark is one way to protect the rights. The trademark licensing existsas the result of an contractual agreement between a licensor and a licensee.The agreement consists of, for instance, the duration; the rights andobligation of the parties; and dispute resolution. The agreement must beregistered to the trademarks office as well as the trademark. The agreementis based on contract law which parties can stablish their right andobligation. The party must obey the contract regarding with the duration,payment of royalty, termination of contract and so on. The utility ofagreement is not only to give benefit to the owner of the marks as licensor,but also to the licensee and state. The license agreement is related to afranchising and distributions hip agreement. All of the agreement give anexclusive right.
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Гутников, Олег, Olyeg Gutnikov, Валерия Смирнова, and Valeriya Smirnova. "On Soviet Trade Marks." Journal of Russian Law 3, no. 1 (December 24, 2014): 0. http://dx.doi.org/10.12737/7250.
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In modern Russia is debated the issue of legal regulation of trademarks, which are well-known in the Soviet time and freely used by many domestic enterprises for homogeneous products such as candy “Belochka”, the “Jubileynoe” cookies, chocolate “Alyonka”, cheese “Yantar”, “Druzhba”, etc. Currently has so-called battle for Soviet trademarks between rights holders, who received the trademark rights in full compliance with the Russian legislation, and the actual users, who do not have time to register them. So in the legal community are mechanisms to address issues related to trademarks: recognition of them entered into general use and lost their distinctiveness, the revocation of their registration as acts of unfair competition; the their nationalization; the introduction of prior use, their mode of collective trademarks or certification, traditional food regulation. Currently in the State Duma of the Russian Federation are considered the bills, aimed at the introduction of the right of prior use in trademarks and issuing a compulsory license. In the article are considered only the arguments against the introduction of the right of prior use and issuance of compulsory licenses in respect of trademarks.
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Yustisia, Fasya, and Catharina Ria Budiningsih. "PENGALIHAN HAK MEREK MELALUI WAKAF BERDASARKAN HUKUM POSITIF INDONESIA DAN PRINSIP SYARIAH." Veritas et Justitia 5, no. 2 (December 27, 2019): 329–51. http://dx.doi.org/10.25123/vej.3616.
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This article discusses the utilization of the Islamic institution of wakaf (an Islamic institution) to transfer ownership or right to use of trademark. The issue at hand is that method of trademark transfer is found regulated by Law No. 20 of 2016 re. Trademark and Geographical Indication whilst procedure and conditions of wakaf is regulated by Islamic/Syariah Law (Law No. 41 of 2004). The author notes that wakaf, understood as transfer of (ownership or proprietorship) of Trademarks, is or should be motivated by religious considerations or made in the public interest. Therefore, transfer done through wakaf will always be made in perpetuity. Nonetheless, the Law no. 41 of 2004 re. wakaf make possible temporary transfer of ownership which may be performed by a license agreement, transferring only right to use the trademark but not the ownership (title) thereof. Another important note to be highlighted is that Islamic law prohibits or considers not appropriate (not halal) trademark of living being or non-kosher products (goods or services).
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da Silva Lopes, Teresa, and Mark Casson. "Brand Protection and the Globalization of British Business." Business History Review 86, no. 2 (2012): 287–310. http://dx.doi.org/10.1017/s0007680512000414.
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In expanding on earlier analyses of the evolution of multinational business that have drawn from concepts of competition and innovation, this study examines the strategies used by British multinationals, between 1870 and 1929, to protect the global reputation of their brands, which were crucial to their survival and success. Even after the passage of new trademark legislation in 1876, enforcement of trademarks remained expensive, and often firms preferred to negotiate, rather than to prosecute violations. Many trademark imitators were based in the newly industrializing countries of the time—the United States, Germany, and Japan—and were part of the British export supply chains as licensees, franchisees, or wholesalers. British firms responded to infringements by lobbying governments, appointing local agents to provide intelligence, and collaborating with other firms.
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Intan Puspanita and Danny Septriadi. "Evaluation of Fairness of Trademarks Royalty Prices in Transfer Pricing Transactions (Case Study of PT X Court Decisions)." JCIC : Jurnal CIC Lembaga Riset dan Konsultan Sosial 3, no. 1 (March 28, 2021): 27–36. http://dx.doi.org/10.51486/jbo.v3i1.52.
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ABSTRACT
This study aims to analyze the arm’s length price of transfer pricing transactions for parties conducting cross-border transactions as well as to see the basis and considerations of the panel of judges regarding royalty on trademark license for tax court decision disputes. The method used in this research is a qualitative approach by looking at the sources of books, documents, national and international journals, as well as laws related to the research topic of transfer pricing. The results of this study concluded that the beneficial owner of IP was Friesland Brands BV, therefore the economic ownership of the IP was Friesland Brands BV because it had developed and continued to develop royalties on the trademark of data, methods, processes, capabilities, and expertise in connection with the milk-making activity. The Panel of Judges did not use the various meanings of a trademark to prove the existence of the trademark. The definition of a trademark that can be used by judges to prove the existence of a trademark is based on international and domestic provisions.
Keywords: arm’s length price, tax dispute, trademarks
ABSTRAK
Penelitian ini bertujuan untuk menganalisis harga wajar atas transaksi transfer pricing bagi pihak-pihak yang melakukan transaksi lintas negara serta melihat dasar dan pertimbangan majelis hakim terkait royalty on trademark lisence atas sengketa putusan pengadilan pajak. Metode yang digunakan dalam penelitian ini yaitu menggunakan pendekatan kualitatif dengan melihat berbagai sumber antara lain yaitu buku-buku, dokumen, jurnal nasional dan internasional, serta undang-undang yang terkait dengan topik transfer pricing. Hasil penelitian ini memperoleh kesimpulan bahwa beneficial owner atas IP adalah Friesland Brands BV, oleh karena itu economic ownership atas IP tersebut adalah Friesland Brands BV karena telah mengembangkan dan melanjutkan untuk mengembangkan royalty on trademark tersebut atas data, metode, proses, kemampuan dan keahlian sehubungan dengan aktivitas pembuatan susu tersebut. Majelis Hakim tidak menggunakan berbagai pengertian merek dagang untuk melakukan pembuktian keberadaan merek dagang tersebut. Pengertian merek dagang yang dapat digunakan hakim untuk membuktikan keberadaan trademark (merek dagang) tersebut berdasarkan ketentuan internasional dan domestik.
Kata Kunci: harga wajar, sengketa pajak, trademarks
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Želvys, Arūnas. "Neišimtinės prekių ženklo licencinės sutarties licenciato teisinės padėties ypatumai." Teisė 71 (January 1, 2009): 163–71. http://dx.doi.org/10.15388/teise.2009.0.290.
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Straipsnyje analizuojami neišimtinės prekių ženklo licencinės sutarties licenciato teisinės padėties ypatumai, susiję su licenciato teise į teisminę gynybą: licenciato galimybė savarankiškai kreiptis į teismą dėl jam suteiktų teisių gynimo, licenciaro vaidmuo užtikrinant licenciato teisių gynimą, teisės į teisminę gynybą įgyvendinimo įtaka licencinės sutarties galiojimui, licencinės sutarties šalių teisės ir pareigos ir kiti susiję klausimai. The article investigates peculiarities of legal status of licensee of non-exclusive trademark license agreement: the possibility of a licensee to apply independently to the court, the role of a licensor in assuring defense of licensee’s rights, impact of a right to judicial defense to validity of a license agreement, rights and obligations of license agreement parties and other related questions.
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Nur, Amirul Mohammad. "IMPOR PARALEL DALAM HUKUM MEREK INDONESIA." Yuridika 30, no. 2 (August 23, 2017): 201. http://dx.doi.org/10.20473/ydk.v30i2.4660.
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Free trade begins with free movement of goods, services, and persons which give chance of importing goods, services, and persons from overseas freely come to Indonesia. Genuine importation in the same goods in a different markets region, will creating it’s own market. The differences of jurisdiction territory and barriers to entry will give opportunity to market participants selling their imports products competitively. Parallel Importation occur when importers bring their genuine products, together with the Licensee (license holder) selling their genuine products competitively-cheaper, in the same time (parallel), with the selling genuine product by Trademark Owner. Trademark protection have important roles on parallel importation, good comprehension of Trademark exploration rights and protection for related parties will avert market participants from business loss. For law enforcement authorities also able to resolve parallel import disputes in a fair way and truly based on Trademark Law.
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Androshchuk, Hennadii. "Сombating unfair registrations and using means of individualization in the conditions of digital transformation." Theory and Practice of Intellectual Property, no. 6 (June 16, 2021): 120–33. http://dx.doi.org/10.33731/62020.234053.
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Key words: intellectual property, unfair competition, means of individualization, valuation,squatter, losses, digital transformation, artificial intelligence
The article examines the economic, legal and institutional aspects of combating unfair registration and use ofmeans of individualization (trademarks, brand names, geographical indications, domainnames) in the context of digital transformation. The formation of theoretical and methodologicaland methodological foundations for the protection of the rights of their owners,improving the efficiency of experts of intellectual property agencies, law enforcementagencies, tools for digital search and use of artificial intelligence (AI) to ensure the effectivenessof the institution of individualization. The economic and legal aspects of foreign(in the jurisdictions of China, USA, EU) and domestic legislative and law enforcementpractices to combat the phenomenon of unfair registration and use of personalization,digital search tools and the use of AI are analyzed. It is shown that over the next fiveyears, 30 to 50% of product searches will be by voice rather than text, so the impact of AIon the way a product is purchased will have significant economic and legal implicationsfor individualization legislation. The means of counteracting unscrupulous applicants inthe USA have been studied. The U.S. Patent and Trademark Office (USPTO) has developedrules under which foreign applicants and trademark owners must be representedby a U.S. licensed attorney when filing trademark applications with the USPTO. Emphasisis placed on the introduction of legislative liability of e-commerce platforms forcounterfeit goods. The analysis of the last changes in the legislation of Ukraine on protectionof trade marks is carried out. It is shown that the new rules change the approachesto registration and protection of trademarks, create the possibility of their fair use.Digitalization, transition to e-document circulation in the Customs Register, improvementof the procedure for destruction of counterfeit goods are important anti-corruptionsteps in the activities of Ukrainian customs in the context of digital transformation of theeconomy.
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Shimada, Makoto. "Nintendo v. MariCar: is street kart rental business free riding on the popular video game characters prohibited in Japan?" Interactive Entertainment Law Review 2, no. 1 (June 2019): 50–54. http://dx.doi.org/10.4337/ielr.2019.01.05.
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You must not make a profit by using a well-known character belonging to someone else without licence. This is a commercial common sense, but a question is on what legal basis such an activity is banned? A character business may involve various intellectual properties, including copyright, trademark, design rights, etc., however, none of these IP rights is directly aimed at protecting characters. Besides, trademarks and design rights shall not take effect unless they are registered at the Patent Office, and characters are not always copyrightable. In several cases, Japanese courts suggest that the Unfair Competition Prevention Act of Japan takes a certain role to protect characters. This case review examines a recent judgment in the case, which deals with the application of this Act for the prevention of free riding on the video game characters.
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Tverezenko, Olena. "Exercise of economic intellectual property rights to wellknown trademarks." Theory and Practice of Intellectual Property, no. 6 (June 16, 2021): 62–72. http://dx.doi.org/10.33731/62020.233966.
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The exercise of intellectual property rights is the realization bythe subject of intellectual property rights of moral and / or economic intellectual propertyrights, the content of which in relation to certain objects of intellectual propertyrights is determined by the Civil Code of Ukraine and other laws. The exercise of intellectualproperty rights is also the realization of economic intellectual propertyrights by other persons on the basis of the permission of the person who has the rightto allow the use of such object of intellectual property rights.The Law «On Amendments to Certain Legislative Acts of Ukraine ConcerningStrengthening the Protection and Protection of Rights to Trademarks and IndustrialDesigns and Counteraction to Patent Trolling» (which entered into force on August16, 2020) has аmended the Law of Ukraine «On Protection of Rights to Marks forGoods and Services» (hereinafter — the Law). The amendments have removed theprovision that a well-known trademark receives the same legal protection as thetrademark for which the certificate is issued. Such changes have created a gap in thelegislation in part of defining what does the exercising of intellectual property rightsto well-known trademarks include.In this connection the following questions arise: (1) can the right to use a wellknownmark (as well as the mark for which the certificate is issued) be the subject ofa license agreement, a commercial concession agreement; (2) whether it is possible tocontribute economic intellectual property rights to a well-known trademark to the authorizedcapital of a legal entity; (3) whether it is possible to transfer such rights onthe basis of an agreement on the transfer of economic intellectual property rights or to provide as collateral. We believe that these issues should be addressed through theadoption of appropriate amendments to Art. 25 of the Law.In our opinion, the right to use a well-known trademark may be the subject of licenseagreements and commercial concession agreements. According to the currentlegislation of Ukraine, it is impossible to transfer economic intellectual propertyrights to a well-known mark to another person.It is expedient to make changes to Art. 25 of the Law, which would provide necessityof creation and functioning of the State register of Ukraine of well-knowntrade marks.The introduction of the proposed amendments to the legislation of Ukraine in thefield of economic intellectual property will help to improve the relevant legal relationsrelated to the exercise of property rights to well-known trademarks.Key words: trademark, well-known trademark, economic intellectual propertyrights, exercise of economic intellectual property rights, assignment (transfer) of economicrights of intellectual property
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Matsumoto, Kei, Christoph Rademacher, and Ayako Suga. "Protecting IP Licenses and Jointly Owned IP in the Age of COVID-19: Insolvency and Force Majeure Events under Japanese Law." GRUR International 70, no. 5 (May 1, 2021): 463–85. http://dx.doi.org/10.1093/grurint/ikab008.
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Abstract This article provides an overview and discussion of a multitude of issues that are relevant for IP licensing under Japanese law. The authors recap the results of the legislative process that predominantly addressed the IP licensee’s position in the case of a licensor's insolvency, including the 2020 amendment to the Japanese Copyright Act, and examine whether a comprehensive reform of IP licensing regulations in Japan would be preferable to also offering better protection to trademarks, trade secrets and data licensees. Given that Japanese companies often agree on jointly owning IP generated in the process of software development and other co-development projects, we analyze the risks of joint ownership compared to non-exclusive licenses. To further illustrate such risks that may be even more significant in cross-border constellations, we conduct a comparative study on the actions that a party commissioning the development of new software can take without obtaining the software developer’s consent under Japanese, US and German patent and copyright law. Furthermore, we examine certain unresolved issues that may arise in the case of a party’s insolvency or the impact of force majeure events, and provide suggestions on how to address these when drafting and negotiating IP license agreements.
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Sichel, Ricardo Luiz, and Luiza de Medeiros Malafaia. "On the equity value of innovation / Do valor patrimonial da inovação." Revista Online de Pesquisa : propriedade intelectual 1, no. 1 (September 18, 2018): 9. http://dx.doi.org/10.9789/2595-9859.2018.v1i1.9-23.
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The technological innovation, according to the present paper has an important role to promote economicdevelopment. The trademark establishes its titleholder to obtain an increase of the value of its intangible asset.The product or the service gains by either its value or how it is considered by the consumer. It enables the ownerto license it, which means his allowance that other companies achieve in order to use a certain brand, withoutbecoming its owner. It is therefore a certain way to rent the use of a trademark. Franchising is a broader wayto fixing the trademark in a worldwide scale, because is not limited to its license, but also include a know-howtransfer.
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Sichel, Ricardo Luiz, and Luiza de Medeiros Malafaia. "On the equity value of innovation / Do valor patrimonial da inovação." Revista Online de Pesquisa : propriedade intelectual 1, no. 1 (September 18, 2018): 9. http://dx.doi.org/10.9789/.2018.v1i1.9-23.
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The technological innovation, according to the present paper has an important role to promote economicdevelopment. The trademark establishes its titleholder to obtain an increase of the value of its intangible asset.The product or the service gains by either its value or how it is considered by the consumer. It enables the ownerto license it, which means his allowance that other companies achieve in order to use a certain brand, withoutbecoming its owner. It is therefore a certain way to rent the use of a trademark. Franchising is a broader wayto fixing the trademark in a worldwide scale, because is not limited to its license, but also include a know-howtransfer.
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Syarief, Elza, Rina Shahriyani Shahrullah, Febri Jaya, and Jendris Sihombing. "Penguatan Hukum Merek dalam Perjanjian Lisensi Guna Peningkatan Taraf Ekonomi Masyarakat di Indonesia." Kosmik Hukum 21, no. 1 (February 5, 2021): 35. http://dx.doi.org/10.30595/kosmikhukum.v21i1.9336.
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The issue of licensing agreements to improve the standard of living of people in Indonesia is very interesting to be studied in depth via intellectual discussions. Various problems should be taken as lessons for Indonesian people, for example: registration of the Toraja coffee trademark by the American businessmen, sambal uleg from Central Java and Gayo coffee by the Dutch and the song Sayang Sayange from Maluku and the legend of Garlic and Onion by Malaysia. The purpose of writing this article is to provide an explanation of the necessity to strengthen understanding of trademark law in the license agreement as an effort to improve the economic level of the Indonesian people. The problems focus on the government actions against the violations of Intellectual Property Rights (IPR) and as well as the roles of the government and society to improve the economic level of society through strengthening trademark law in license agreements. The research was conducted by using a normative legal research. The result of the research described in this article is that the economic level of the community can be increased by conducting a franchise business, providing opportunities for the franchisor to exploit economic rights in order to multiply and get the maximum profit at a low cost because it is borne by the franchisee.Keywords: Trademark, License Agreement, Economic Strata
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Horman, Edbert Seligshan. "The Exclusive Rights of Licensees in Parallel Import Practices." Yuridika 36, no. 1 (January 1, 2021): 57. http://dx.doi.org/10.20473/ydk.v36i1.19378.
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Parallel imports are one of the most interesting and unique phenomena of international trade. On one hand, it applies competition law, while on the other, trademark law and the customs law also apply in this activity. Parallel imports occur when genuine goods are imported in parallel (concurrently) to goods imported by a licensee. These parallel imports are then sold at a cheaper price than that of the goods of the licensee. This parallel import activity is inconsistent with the exclusive rights that the licensee receives under the licensing agreement it makes with the owner of the trademark. This exclusive right is essentially monopolistic, entitling the licensee to prevent all parties with the commercial intention of selling the same or similar goods as their own. However, the right to monopoly is limited for the sake of a fair competition. The licensee can sue to get compensation in parallel importation base on unjust enrichment principle. Moreover, parallel importation can be inhabited by enforcing procedural and administration regarding import of goods such as, Indonesian national standard and label in bahasa
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Clement, Annie. "Intellectual Property and the Media: An Examination of Copyright, Trademark, and Right of Publicity in Sport." International Journal of Sport Communication 4, no. 1 (March 2011): 82–98. http://dx.doi.org/10.1123/ijsc.4.1.82.
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This treatise addresses the elements of the law of intellectual property (IP)—namely, copyright, trademark, and right of publicity—most important to members of the sport media. Statutes and court decisions under copyright include definition, rights of owners, fair use, licenses, secondary transmission, file sharing, and work for hire. Under trademark name confusion, dilution, trade dress, abandonment, and cancellation are described, and the current use of the right of publicity, a new member of the IP group, among athletes and entertainers is outlined. Infringement and criminal violation of IP rights are mentioned. The results of court cases focus on IP decisions in sport.
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Yunika, Afis, B. Rini Heryanti, and Tri Mulyani. "Perlindungan Hukum Merek Dagang Coca-Cola Terhadap Pelanggaran Persamaan Pada Pokoknya Ditinjau Menurut Undang-Undang Nomor 20 Tahun 2016 Tentang Merek Dan Indikasi Geografis." Hukum dan Masyarakat Madani 7, no. 2 (May 14, 2017): 81. http://dx.doi.org/10.26623/humani.v7i2.1024.
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<p>Perlindungan hukum merek dagang Coca-Cola terhadap pelanggaran persamaan pada pokoknya ditinjau menurut UU Nomor 20 Tahun 2016. Bagaimana kendala dan upaya mengatasi pelanggaran persamaan pada pokoknya terhadap merek dagang Coca-Cola. Metode penelitian yang digunakan dalam penulisan skripsi ini adalah penilitian yuridis empiris yaitu, cara prosedur yang dipergunakan untuk memecahkan masalah penelitian dengan meneliti data sekunder untuk dilanjutkan dengan mengadakan pengamatan secara objektif di PT Coca-Cola. Berdasarkan hasil penelitian yang ditinjau dari UU Nomor 20 Tahun 2016 tentang perlindungan hukum merek dagang Coca-Cola terhadap persamaan pada pokoknya, yakni menggunakan perlindungan hukum preventif dan perlindungan hukum represif. Perlindungan preventif ialah Perlindungan hukum sebelum terjadi tindak pidana atau pelanggaran hukum terhadap merek, sedangkan perlindungan hukum represif ialah perlindungan hukum terhadap merek manakala ada tindak pidana merek atau pelanggaran hak atas merek. Sementara kendala dan upaya mengatasi pelanggaran persamaan pada pokoknya yaitu, masih banyaknya produk yang masih secara luas diperdagangkan di pasaran, sedangkan upaya mengatasinya adalah dengan penegakan hukum merek-merek dagang yang melakukan pelanggaran persamaan pada pokonya dan dalam penyelesaian permasalahan pelanggaran merek, dapat melalui jalur non litigasi dengan gugatan ganti rugi atau pencabutan lisensi merek dagang dari pasaran luar.</p><p><em>The protection of the law of trademarks Coca Cola of the transgression of the similarities in the point reviewed according to Act No. 20 2016 and how obstacles and efforts to resolve the breach of equality at the point of a trademark Coca-Cola.The research method used in the writing of this bachelor theses is anextensive micro insurance nomative empirical namely, how to procedures that are used to solve the problem with the research examines the secondary data to continue to make observations it objectively in PT Coca-Cola. Based on the results of research reviewed from the Act No. 20 2016 about legal protection trademarks Coca-Cola against the similarities in the point, i.e. using legal protection preventive and repressive legal protection. Preventive protection is the protection of the law before the criminal act or breach of the law against other brands, while the protection of the law is the protection of the law against the repressive brands when there is a criminal act brands or brand rights violations. While the problems and efforts to resolve the breach of common ground on the point is that there are still many products that are still widely traded in the market, while efforts to solve them is with law enforcement the brands trademarks that do breach similarities and solving the problems brand violations, can through non line of litigation with the spurious compensation or trademark license revocation from the market outside.</em></p>
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Androshchuk, Hennadii. "Сombating unfair registrations and using means of individualization in the conditions of digital transformation." Theory and Practice of Intellectual Property, no. 1 (June 11, 2021): 48–67. http://dx.doi.org/10.33731/12021.234192.
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Key words: intellectual property, unfair competition, means of individualization, valuation,squatter, losses, digital transformation, artificial intelligence
The article examines the economic, legal and institutional aspects of combating unfair registration and useof means of individualization (trademarks, brand names, geographical indications,domain names) in the context of digital transformation. The formation of theoreticaland methodological and methodological foundations for the protection of the rights oftheir owners, improving the efficiency of experts of intellectual property agencies, lawenforcement agencies, tools for digital search and use of artificial intelligence (AI) toensure the effectiveness of the institution of individualization. The economic and legalaspects of foreign (in the jurisdictions of China, USA, EU) and domestic legislativeand law enforcement practices to combat the phenomenon of unfair registration anduse of personalization, digital search tools and the use of AI are analyzed. It is shownthat over the next five years, 30 to 50% of product searches will be by voice ratherthan text, so the impact of AI on the way a product is purchased will have significanteconomic and legal implications for individualization legislation. The means of counteractingunscrupulous applicants in the USA have been studied. The U.S. Patentand Trademark Office (USPTO) has developed rules under which foreign applicantsand trademark owners must be represented by a U.S. licensed attorney when filingtrademark applications with the USPTO. Emphasis is placed on the introduction oflegislative liability of e-commerce platforms for counterfeit goods. The analysis of thelast changes in the legislation of Ukraine on protection of trade marks is carried out.It is shown that the new rules change the approaches to registration and protection oftrademarks, create the possibility of their fair use. Digitalization, transition to e-documentcirculation in the Customs Register, improvement of the procedure for destructionof counterfeit goods are important anti-corruption steps in the activities ofUkrainian customs in the context of digital transformation of the economy.
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Želvys, Arūnas. "Prekių ženklo licencinės sutarties ir franšizės sutarčių santykis." Teisė 73 (January 1, 2009): 149–57. http://dx.doi.org/10.15388/teise.2009.0.265.
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Straipsnyje analizuojami prekių ženklo licencinės sutarties ir franšizės sutarties santykio aspektai, susiję su šių sutarčių kvalifikavimo ir atskyrimo problematika. The article investigates correlation between trademark license and franchise agreement. The analysis is mainly focused on problems of qualification and distinguishing between the contracts.
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Purwaningsih, Endang, Nurul Huda, and Nelly Ulfah A.R. "PRODUCT CERTIFICATION AND LEGAL PROTECTION TO ENHANCE INDONESIAN TRADITIONAL HERBAL PRODUCTIONS." Mimbar Hukum - Fakultas Hukum Universitas Gadjah Mada 27, no. 3 (February 10, 2016): 566. http://dx.doi.org/10.22146/jmh.15885.
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This study is aimed to empower traditional herbs producer and help legal protection of Indonesian traditional medicines, implementing Participatory Research and juridical-sociological approaches. Data
were collected through literary, questionnaire, interview and Focus Group Discussion. The first year study revealed that Herbal Producer Association worked with all members, persuading government offices to get product certification and effective trademark licenses. In the second year study the researchers and Producers Association trained and facilitated vendors to endorse trademark, label registry, and markets shares. Producers maintain traditional medicine management, because product certification is hard to achieve.
Penelitian ini bertujuan untuk memberdayakan produsen jamu/OT dan membantu perlindungan hukumnya, dengan memanfaatkan pendekatan penelitian partisipatoris dan sosiologis yuridis. Data dikumpulkan dengan literatur, kuesioner, wawancara dan Focus Group Discussion (FGD). Pada tahun pertama organisasi gabungan pengusaha jamu (GP Jamu) bersama-sama dengan seluruh anggotanya mendorong pemerintah untuk perolehan sertifikasi produk izin edar dan merek secara efektif. Pada tahun kedua, peneliti dan gabungan pengusaha jamu melakukan pelatihan guna perolehan izin edar, pendaftaran merek, dan peningkatan pemasaran. Para pengusaha jamu tradisional perlu terus menerus didampingi karena perolehan izin edar terkesan sulit.
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Mehdipour, Mohammad, and Parviz Bagheri. "The Franchise Agreement in International Trade: its Advantages and Disadvantages." Cuestiones Políticas 39, no. 69 (July 17, 2021): 296–316. http://dx.doi.org/10.46398/cuestpol.3969.17.
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The aim of the article is to analyze the implications of the franchise agreement in international trade. One of the contracts that is usually registered after the appearance and registration of property rights, and especially after the development of trademark rights, is the franchise agreement. A franchise agreement is a contract entered into between the franchisor and the franchisee as the owner of the intellectual property rights. In other words, the franchisee often uses trademark rights and intellectual property rights owned by the franchisor, which have a limited duration. It is concluded that, in franchise agreement, there is a right to enforce the franchisor's business method, which is implemented within the network (this method includes the use of intellectual property rights and know-how). This contract has detailed terms and is closely related to intellectual property rights and competition rights. The franchise must be distinguished from the distribution contract, the concessionaire, and the license. Under this agreement, the franchisee enters the franchise network and agrees to use the franchisor's method of negotiation and pay royalty-free payments instead.
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WILLOUGHBY, KELVIN W. "INTELLECTUAL PROPERTY MANAGEMENT AND TECHNOLOGICAL ENTREPRENEURSHIP." International Journal of Innovation and Technology Management 10, no. 06 (November 28, 2013): 1340027. http://dx.doi.org/10.1142/s0219877013400270.
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This paper investigates the distinctive technology protection strategies of entrepreneurial technology firms. In contrast with much popular opinion, it is reported that intellectual property features more prominently in the business of small entrepreneurial firms than it does in the business of large, established mature firms. The intellectual property portfolios of technology firms of all sizes and ages exhibit a rich array of instruments in addition to patents for protecting technology, including trade secrets, trademarks and copyright, together with licenses to externally sourced technology. The intellectual property profiles of technology firms appear to be influenced by their context, organizational profiles and corporate goals and by the character of their technology.
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Kapitsa, Y. "THE REFORM OF TRADE MARS PROTECTION IN THE EUROPEAN UNION AND IT’S IMPACT ON LEGISLATION OF UKRAINE." ACTUAL PROBLEMS OF INTERNATIONAL RELATIONS 1, no. 127 (2016): 80–86. http://dx.doi.org/10.17721/apmv.2016.127.1.80-86.
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The adoption of the EU in 2015 the Directive 2015/2436 and Regulation 2015/2424 resulted in significant changes for the protection of trade marks at the level of the Member States and the EU trade mark. These changes are the result of the policy of the entire approximation of Member States laws in all issues of trademarks, which differs from the harmonization of «minimum rights» and the EU approach to harmonization of legislation on other industrial property objects. Comparison of changes to EU legislation and legislation of Ukraine demonstrates the necessity of making a number of amendments to national legislation regarding registration of scent and other non- traditional marks; clarify the scope of protection of rights; grounds for refusal of registration; concluding license agreements, protection of collective marks etc. It is essential to provide the clarification of the procedure for registration of trademarks in Ukraine to ensure compliance with the registration procedure, established by the Directive 2015/2436.
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Ancevska Netkovska, Katerina, Jasmina Tonic Ribarska, Aleksandra Grozdanova, and Zoran Sterjev. "Patents and licensing in pharmaceutical industry." Macedonian Pharmaceutical Bulletin 61, no. 01 (2015): 51–59. http://dx.doi.org/10.33320/maced.pharm.bull.2015.61.01.006.
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Intellectual property rights (IPR) have been defined as ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property. IPR provide certain exclusive rights to the inventors or creators of that property, in order to enable them to reap commercial benefits from their creative efforts or reputation. There are several types of intellectual property protection like patent, copyright, trademark, etc. Patent is recognition for an invention, which satisfies the criteria of global novelty, non-obviousness, and industrial application. IPR is prerequisite for better identification, planning, commercialization, rendering, and thereby protection of invention or creativity. Each industry should evolve its own IPR policies, management style, strategies, and so on depending on its area of specialty. Pharmaceutical industry currently has an evolving IPR strategy requiring a better focus and approach in the coming era. The protection of inventions with patents in the pharmaceutical industry have a specific role in the development of society and represent one of the drivers of economic development. The license agreements are considered as one of the most common types of transfer of industrial property rights. The right holders often transfer their rights to patents by concluding licensing agreement. While the patent license may give the license a right to use the technology many license agreements have provisions for the transfer of know-how in addition to the patent.
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Ogachi, Daniel, Lydia Bares, and Zoltan Zeman. "Innovation and Scientific Research as a Sustainable Development Goal in Spanish Public Universities." Sustainability 13, no. 7 (April 2, 2021): 3976. http://dx.doi.org/10.3390/su13073976.
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One of the Sustainable Development Goals for 2030 is building resilient infrastructure, promoting inclusive and sustainable industrialisation, and fostering innovation. This paper aims to analyse the possible consequences of stimulating commercial exploitation of academic research, encouraged by recent policy initiatives and legislative changes, on the quantity and quality of scientific knowledge in Spain’s public universities. We collected data of innovation variables (national patents, R&D and consultancy agreements, services rendered, licenses and PCT extensions and spin-offs), publications and number of citations for 48 Spanish public universities in 2009–2018 from Observatorio IUNE, which obtains data from the Spanish Patent and Trademark Office, the Network of Research Results Transfer Offices and Web of Science. The results of linear regressions models showed that universities that render more services and have a greater number of PCTs (patent cooperation treaties), have a positive impact on the quantity and quality of the publications in Spanish universities. However, the number of national patents has no impact on the scientific output. Finally, universities with a greater number of patents have a lower number of citations.
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Pate, John R. "Andean Group: Commission Decision 291 - Common Code for the Treatment of Foreign Capital and on Trademarks, Patents, Licenses and Royalties." International Legal Materials 30, no. 5 (September 1991): 1283–94. http://dx.doi.org/10.1017/s0020782900019070.
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Saunders, Adam, Teresa Scassa, and Tracey P. Lauriault. "Legal Issues in Maps Built on Third Party Base Layers." GEOMATICA 66, no. 4 (December 2012): 279–90. http://dx.doi.org/10.5623/cig2012-054.
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The recent growth in citizen map-making ability has been brought about in part by the availability of base layers of geospatial information on which maps can be built, as well as software tools that allow geographic information to be represented. However, the legal relationship between the creator of the map and the owner of the base layer has received relatively little attention. In this paper, we consider legal issues regarding volunteered geographic information (VGI) submitted to third-party geographic information systems (GIS). This combination raises issues of copyright, database rights, trademark, and End User License Agreements (EULAS). The paper will consider the IP rights on which the EULAs are founded and the corresponding rights of those who build their own maps onto the base layers; analyze some of the key EULAs in this area, and identify important issues for those who create maps using these base layers.
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Arrieta Posada, Juan Gregorio, Victoria Eugenia Botero Herrera, and María Jimena Romano Martínez. "Benchmarking sobre manufactura esbelta (lean manufacturing) en el sector de la confección en la ciudad de Medellín, Colombia." Cuadernos de difusión 15, no. 28 (June 30, 2010): 141–70. http://dx.doi.org/10.46631/jefas.2010.v15n28.06.
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This document shows the results of a benchmarking study among different firms from the clothing industry that seeks to evaluate their degree of implementation in Lean Manufacturing during their respective productive processes. The study mainly targets firms that produce blue jeans, cotton shirts and t-shirts. Indeed, this industrial sector in the city of Medellin is highly developed and one of the most dynamic, thus the interest to perform an evaluation in this area. To achieve the benchmarking, a questionnaire was designed and applied to the different firms that were visited. The most significant result obtained was that Lean Manufacturing techniques were not prevalent within the general public. Only those companies with years in the business, exporters or foreign trademarks licensees, were knowledgeable of their application and development.
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Sulasno, Sulasno,, and Uul Nabila. "Penerapan Perlindungan Hukum Kekayaan Intelektual Atas UMKM Melalui Peogram Sabtu Minggu Di Kota Serang." Jurnal Ilmu Administrasi Negara ASIAN (Asosiasi Ilmuwan Administrasi Negara) 8, no. 01 (October 12, 2020): 27. http://dx.doi.org/10.47828/jianaasian.v8i01.29.
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Micro, Small and Medium Enterprises (UMKM) have an important and strategic role in national economic development, UMKM in Serang City have the potential to drive the regional economy of UMKM into one of the economic pillars that drives the wheels of the economy in Indonesia. Based on data from the Serang City Industrial, Trade and Cooperatives Office, the total number in each district of the city and district of Serang reaches 10,132 UMKM, 499 MSMEs that have a small micro business license (UMK). This proves that the awareness of MSME entrepreneurs on the importance of a business permit, the importance of a brand in a product is still minimal. On this basis, we make a program called law weekend, which is a legal approach to the public or business people so that they can understand the importance of copyright, the importance of brands and contribute to trademark registration in order to protect UMKM.
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SLAUGHTER, JOSEPH P. "Harmony in Business: Christian Communal Capitalism in the Early Republic." Enterprise & Society 21, no. 3 (March 2, 2020): 716–67. http://dx.doi.org/10.1017/eso.2019.49.
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Scholars increasingly acknowledge the contingent, varied, complex nature of capitalism, yet overlook a viable vision of the early nineteenth-century United States: communal capitalism. Communal societies proliferated in the early United States as a way to regulate the market. The most industrious, materially successful model of this approach was George Rapp’s Harmony Society, established in 1805. Rapp was a radical Pietist, immigrating with his followers from Württemberg in order to establish a purified community that would persevere into the millennium he predicted was imminent. Despite a ban on private property, the Harmonists embraced the market, building textile factories and conducting market activity under the moniker “Rapp & Associates.” Technologically innovative, shrewd in business, and dogged in pursuit of a “divine economy,” the example of the Harmony Society helps us better understand how religious businesses helped shape the early American capitalist system and, specifically, the contributions of German Pietism to economic thought in the Atlantic world. Ultimately, we discover how the Harmonists’ communal capitalism forsook wages and private property, while embracing stocks, bonds, leases, mortgages, patents, trademarks, licenses, litigation, and contracts as they built an incredibly successful and wealthy manufacturing community in the then-western United States, even as George Rapp’s authoritarian leadership style created tensions within his workforce of immigrant women, men, and children.
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Sunder, Madhavi. "Intellectual Property in Experience." Michigan Law Review, no. 117.2 (2018): 197. http://dx.doi.org/10.36644/mlr.117.2.intellectual.
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In today’s economy, consumers demand experiences. From Star Wars to Harry Potter, fans do not just want to watch or read about their favorite characters— they want to be them. They don the robes of Gryffindor, flick their wands, and drink the butterbeer. The owners of fantasy properties understand this, expanding their offerings from light sabers to the Galaxy’s Edge®, the new Disney Star Wars immersive theme park opening in 2019.Since Star Wars, Congress and the courts have abetted what is now a $262 billion-a-year industry in merchandising, fashioning “merchandising rights” appurtenant to copyrights and trademarks that give fantasy owners exclusive rights to supply our fantasy worlds with everything from goods to a good time. But are there any limits? Do merchandising rights extend to fan activity, from fantasy-themed birthday parties and summer camps to real world Quidditch leagues? This Article challenges the conventional account, arguing that as the economic value of fantasy merchandising increases in the emergent “experience economy,” intellectual property owners may prove less keen on tolerating uncompensated uses of their creations. In fact, from Amazon’s Kindle Worlds granting licenses for fan fiction, to crackdowns on sales of fan art sold on internet sites like Etsy, to algorithms taking down fan videos from YouTube, the holders of intellectual property in popular fantasies are seeking to create a world requiring licenses to make, do, and play. This Article turns to social and cultural theories of art as experience, learning by doing, tacit knowledge, and performance to demonstrate that fan activity, from discussion sites to live-action role-playing fosters learning, creativity, and sociability. Law must be attentive to the profound effects these laws have on human imagination and knowledge creation. I apply the insights of these theories to limit merchandising rights in imaginative play through fair use, the force in the legal galaxy intended to bring balance to intellectual property law.
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Taliento, Marco. "In the Midst of Crisis: Knowledge Assets and Operating Efficiency of Italian Listed Companies." International Journal of Business and Management 12, no. 7 (June 6, 2017): 70. http://dx.doi.org/10.5539/ijbm.v12n7p70.
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Firms’ knowledge assets represent vital resources that contribute, in general, to corporate performance and value creation. At an earlier stage, they are expected to help enhance the operational efficiency of firms they belong to. In this light, under a Resource-Based Theory framework, we intend to find whether and to what extent this expectancy is verified also during the recent crisis in Italy. In more detail, we considered 612 firm-year observations relating to the Italian listed companies during three consecutive years - 2010, 2011 and 2012 (when the financial crisis reached its peak in Italy) - analysing overall about 7.000 data/numbers under a Fixed Effects Panel Data Model. The findings are robust: we document a significant positive correlation between Operational Efficiency and Patent assets & Intellectual Property Rights, Goodwill, Trademarks & Licenses, while we do not find a correlation with reference to Research & Development Capital (and Advertising investments), also controlling for employees, leverage and time/sector dummies. In the midst of a very turbulent period, most intellectual assets (the former) appear from the efficiency point of view more valuable and reliable than others (the latter) in hampering the profitability drop. Hence, unlike the tangible and financial assets, such resources are prospected to be strategic levers that make it possible to maintain efficiency or to enable a faster recovery in terms of wasted efficiency. That is, in turbulent times, technology, marketing-related and contractual-legal assets appear significantly associated with operational efficiency and therefore beneficial to corporate results.
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Casey, Gretchen L. "Courts React." Texas A&M Journal of Property Law 5, no. 3 (April 2019): 601–13. http://dx.doi.org/10.37419/jpl.v5.i3.6.
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Over the past few years, the rise in popularity of a genre of You- Tube videos known as “reaction videos” has resulted in controversy for various reasons. The United States District Court in Hosseinzadeh v. Klein, a landmark case for the genre, described the “reaction videos” as “a large genre of YouTube videos . . . [that] vary widely in terms of purpose, structure, and the extent to which they rely on potentially copyrighted material.” According to the Hosseinzadeh opinion, “[s]ome reaction videos. . .intersperse short segments of another’s work with criticism and commentary, while others are more akin to a group viewing session without commentary.” Essentially, reaction videos are exactly what the name suggests: a video showing a person or group of people reacting to the work of another, which by nature requires the incorporation of the work being reacted to for the viewer’s reference. The first time that controversy arose out of the “reaction” genre was in 2015 when the Fine Brothers, the creators of a popular YouTube channel known for its “Kids React” series along with several other “reaction video” series, applied to trademark the term “react.” The brothers did so with the intention to create a program called “React World,” through which they would license out the “reaction video” format to other video creators. This endeavor came not long after the Fine Brothers criticized Ellen DeGeneres for allegedly using their “re- action” format in a segment on her television show, suggesting the brothers’ belief that they were the sole owners of what is, in reality, a widely-used format. As a result, YouTube viewers became distrustful of the Fine Brothers’ intentions in trademarking the format, and viewers criticized them to the point that they issued a public apology in February of 2016 in which they announced their decision to “[r]escind all. . .‘React’ trademarks and applications” and “[d]iscontinue the React World program.” Later in 2016, reaction videos would again become the subject of controversy when Ethan and Hila Klein, the husband-and-wife creators of the popular YouTube comedy channel H3H3 Productions, were sued by Matt Hosseinzadeh of the decidedly less popular You- Tube channel, Matt Hoss Zone, for copyright infringement. Hosseinzadeh alleged copyright infringement for the use of segments of his video, “Bold Guy vs. Parkour Girl,” in a humorous reaction video made by the Kleins.8 What resulted was the aforementioned Hosseinzadeh v. Klein opinion, which set a precedent that will hopefully allow future reaction video creators to produce and share content without their creativity being stifled by the looming risk of copyright infringement lawsuits. Hosseinzadeh alleged that a video, which was part of a series of videos, starring himself as “Bold Guy,” “in which the Bold Guy flirts with a woman and chases her through various sequences” was infringement. Hosseinzadeh alleged that the Kleins’ video entitled “The Big, The BOLD, The Beautiful,” infringed upon “Bold Guy vs. Parkour Girl,” as it featured the couple “comment[ing] on and criticiz[ing] [his] video, playing portions of it in the process.” Accepting the Kleins’ motion for summary judgment, which pleaded the fair use defense, the court held that its “review of the. . .videos makes it clear that [the claim] in which plaintiff alleges that defendants in- fringed plaintiff’s copyrights, must be decided in defendants’ favor.”
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Mackay, Wayne A., Steve George, Tim Davis, Mike Arnold, Dan Lineberger, Jerry Parsons, and Larry Stein. "Texas SuperStars: The Coordinated Educational Marketing Assistance Program in Texas." HortScience 35, no. 4 (July 2000): 565B—565a. http://dx.doi.org/10.21273/hortsci.35.4.565b.
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The Coordinated Educational Marketing Assistance Program (CEMAP) is one of the oldest marketing assistance programs for ornamentals in the United States. The goal of this program is to identify outstanding plants for Texas and to provide support for the nursery industry, thereby making plants with superior performance available to the people of Texas. The CEMAP program is a cooperative effort between the Texas nursery industry and Texas A&M Univ. The CEMAP Executive Board has eight individuals representing extension, research, and teaching plus two administrative liasions and the Industry Advisory Board has ≈50 members from all segments of the ornamentals industry in Texas. Funding for the CEMAP program comes from direct industry support and from the public through the sale of plant tags or other promotional materials which bear the Texas Superstars logo. The logo is trademarked and licensed to printing companies who handle the administration of royalties to the program. The Executive Board makes the final decision about which plants are designated Texas Superstars. Promotional support for the plants is provided by CEMAP through point of purchase materials and publicity through print, radio, and television. In addition, the Texas Nursery and Landscape Association in cooperation with the Texas Department of Agriculture are conducting a publicity campaign to inform the public about Texas Superstars.
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Burkovskaya, Alla, and Dmytro Parakonnyi. "Foreign economic activity and its impact on the balance of payments of Ukraine." Modern Economics 23, no. 1 (October 27, 2020): 20–25. http://dx.doi.org/10.31521/modecon.v23(2020)-03.
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Introduction. The payment balance is an indicator of the state and development of the national economy, systematically reflects the transactions between economic systems around the world, which allows us to assess the country’s participation in the international division of labor. It also plays an important role in the mechanism of currency regulation. Control of the payment balance in the context of implementing measures to eliminate imbalances in the economy, implementing a balanced foreign economic, monetary, exchange rate policy, establishing economically sound amounts of gold and foreign exchange reserves, developing adaptive mechanisms to attract external financing are extremely important. The problem and its solution should become the main direction of state policy of Ukraine. Purpose. The aim of this article is to study the impact of the real state of foreign economic activity on the payment balance of Ukraine and analysis of the reviewed impact indicators. Results. The article considers the concepts and individual indicators of the payment balance of Ukraine and shows the components of the payments balance. The main indicators of foreign trade, including the volumes of imports and exports and their dynamics, have been reviewed in detail. The current state of Ukrainian foreign economic activity in general has been analyzed. The concept of the payment balance has been indicated and the connection between the change in the payment balance depending on the change of certain indicators of Ukraine’s foreign economic activity, which are closely interrelated, has been determined. Conclusions. The main factor that negatively affects Ukraine’s payment balance is the large balance of goods deficit. The strategy to reduce the payment balance deficit should include the following elements: taking the necessary measures to eliminate internal economic imbalances; to guarantee the provision of export credits to producers, insurance against economic and political risks, the introduction of a preferential depreciation regime for fixed assets and the provision of financial benefits and other loans in exchange for the fulfillment of specific obligations of the export program; use international legal standards to regulate the payments balance; regulation of expenditures and revenues of the state budget, the use of risk insurance instruments in the financial system; increase revenue and revenue rates to increase trademark patents, licenses, and references to scientists and technicians.
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Fammler, Michael A., and Christoph Krieger. "The Fate of a Trademark License in the Case of Bankruptcy of the Licensor – The U.S. Supreme Court Decision Mission Product Holdings Inc. v Tempnology, LLC in the Light of German Law & Practice." GRUR International 69, no. 1 (January 1, 2020): 35–38. http://dx.doi.org/10.1093/grurint/ikz003.
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Gilmore, Anna B., Allen W. A. Gallagher, and Andy Rowell. "Tobacco industry’s elaborate attempts to control a global track and trace system and fundamentally undermine the Illicit Trade Protocol." Tobacco Control 28, no. 2 (June 13, 2018): 127–40. http://dx.doi.org/10.1136/tobaccocontrol-2017-054191.
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BackgroundThe Illicit Trade Protocol (ITP) requires a global track and trace (T&T) system to reduce tobacco smuggling. Given the tobacco industry’s (TI) historical involvement in tobacco smuggling, it stipulates that T&T ‘shall not be performed by or delegated to the tobacco industry’. This paper explores the rationale for & nature of the TI’s effors to influence the ITP & its T&T system.MethodsAnalysis of leaked TI documents and publicly available data; ,investigation of front groups, trademark and patent ownership.FindingsGrowing & diverse sources of evidence indicate that the TI remains involved in tobacco smuggling and that TI cigarettes account for around two-thirds of the illicit cigarette market. The TI therefore has a vested interest in controlling the global T&T system aimed to curtail this behaviour. To this end, Philip Morris International (PMI) adapted its pack marker system, Codentify, to meet T&T requirements, licensed it for free to its three major competitors who then collectively promoted it to governments using front groups and third parties including companies claiming to be independent despite clear TI links. PMI also sought to suggest Codentify was independent by selling some parts of its intellectual property on Codentify while retaining others, leaving a complex web of shared interests. In Africa, British American Tobacco used payments to obtain data suggesting its smaller competitor companies were evading taxes and secure influence with tax authorities. Regulatory capture has been enhanced by a public relations effort involving TI funding for conferences, training, research, and international police and anti-corruption organisations. Collectively this has created public messaging and a powerful network of organisations supportive of the TI’s misleading postion on illicit.ConclusionsGovernments should assume the TI seeks to control T&T systems in order to avoid scrutiny and minimise excise tax payments and that any T&T system based on Codentify, on intellectual property currently or previously owned by the TI, or being promoted or implemented by companies with TI links, is incompatible with the ITP and would not serve to reduce illicit trade.
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Firdausy, Sheril, and Anajeng Esri Edhi Mahanani. "Legal Protection Effort towards Mark Owner from the Share-in Jar Cosmetic Trade." SIGn Jurnal Hukum 3, no. 1 (September 3, 2021): 26–39. http://dx.doi.org/10.37276/sjh.v3i1.113.
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This study aims to analyze and understand the legal protection towards the mark owner from the share-in jar cosmetic trade and the legal consequences for business actors who do share-in jar cosmetic trade. The type of legal research used in this study is a normative juridical legal research method. The data collection in this study was conducted through a literature study from the laws and regulations, journals, research results, and books. The data analysis used in this research is the descriptive analysis method. The results of the study show that the legal protection towards the mark owner from the share-in jar cosmetic trade can be carried out through preventive and repressive legal protection efforts. Legal protection efforts are preventively carried out by registering the mark to get legal protection as a legal mark owner. Repressive legal protection efforts for trademarks can be done by litigation dispute resolution and non-litigation dispute resolution. The legal consequences for business actors who do share-in jar cosmetic trade are compensate for damages and/or ceasing all acts related to mark use. Therefore, it is recommended to the mark owner to provide cosmetics with trial or sample sizes. In this case, so that consumers try first about their compatibility with these cosmetics. On the other hand, business actors doing share-in cosmetic jar trade must make a license agreement with the mark owner. Furthermore, the government needs to include criteria for violations of right on mark in laws and regulations. This is purpose to increase legal protection towards the mark owner from the share-in jar cosmetic trade in the future.
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Fhelboom, Reda, and Bashir Brika. "BOTTLED WATER SOLD IN THE TRIPOLI MARKETS: CHALLENGES AND SHORTCOMINGS." Water Conservation and Management 4, no. 2 (May 27, 2020): 73–77. http://dx.doi.org/10.26480/wcm.02.2020.73.77.
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Bottles of water, by different trademarks which lack of the standard specifications, have overwhelmed shops and markets in Libya. Despite the fact that the number of plants and factories of bottled water is increasing rapidly, there has not been any serious intention on the part of governmental bodies to take action against the unlicensed factories. This has led to the quality of bottled water in many cases violating the required standards of chemical and physical properties for the potable water, which threatens the public health. The aim of this paper was first, to investigate whether if these bottled water do really meets the international and Libyan standards of bottled water, and second to point out the actions taken by the responsible authorities as well as other related governmental/non-governmental organizations. The paper examined four random samples of bottled water sold in Tripoli during January 2019 and measured some of its physicochemical properties, such as total dissolved solids (TDS), pH, sodium, potassium and calcium. The results indicated that all the experimental values were different from what was written on the samples’ labels. The percentage of these differences ranged from 2% to 650 %. The statistical data of TDS (labeled-measured) was found to be 78.725 mg/l with a standard deviation of 33.91758 mg/l, and t-test with p = 0.019 (P ≤ 0.05), which means results are significant. It was also observed that all samples violated the Libyan standards in not providing all the required data on their labels; 25% of samples do not include water source, 50% of samples do not mention the source of the water, 75% of samples do not mention license number, and 50% of samples do not provide any written statement regarding the storage conditions, which means that all the samples must be withdrawn from the market without the need for chemical or biological testing.
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Karamushka, Oleksandr, Svitlana Moroz, and Natalia Vasylieva. "INFORMATION COMPONENT OF INNOVATIVE SUPPORT FOR AGRICULTURAL ENTERPRISES CAPITAL." Baltic Journal of Economic Studies 4, no. 4 (September 2018): 145–50. http://dx.doi.org/10.30525/2256-0742/2018-4-4-145-150.
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The importance of researching the information component of innovative capital support is due to the formation of the knowledge economy and the need to increase the competitiveness of domestic agrarian enterprises. Innovative renewal of the capital of agrarian enterprises is a key to improving the efficiency of their work: increasing production and sales, reducing production costs, and increasing productivity. At the same time, the problem of the influence of the information component of innovation on capital remains open, which is a reserve for increasing the efficiency of its use and allows us to develop approaches to ensure the profitability growth of agrarian enterprises. Separate aspects of the use of innovations in the agrarian sector of the economy were considered by J. Sayer, K. G. Cassman, H. van Es, J. Woodard, G. Ye. Pavlova, and others. The aim of this article is to research interconnections that arise between the information component of innovation and types of the capital of an enterprise, taking into account agrarian specificity. Methodology. During the research and writing of the article, methods were used: monographic, abstract-logical, mathematical statistics, observation. Results. Any innovation is dual in nature, including the material foundation and the information component. Innovation on the impact on economic processes of enterprises appropriately divided into production (technical, technological, chemical, biological, and managerial) and sales (product and marketing). According to the results of the research, the scheme of the influence of types of innovation on the types of the capital of agrarian enterprises was developed. Empirical studies have shown that the information component of production innovation is methodical and instructional documentation, warranty contract obligations, production licenses, patents, plant and animal breed rights, databases and electronic services of an innovator with their offers, automated information management systems of the enterprise, staff training programs. The information component of sales innovation are the certificates of products quality, brands and trademarks, the standards of the quality of products of the importing countries, characteristics of target market segments, automated customer databases, licensing agreements for the sale of product, data on monitoring of the sectoral markets, pre-contracted deliveries of products, tools e-commerce, etc. Conclusions. The information component of various types of innovation that are inherent in agrarian production is considered. Relationships between types of capital and innovation are explored. The specificity of the use of the information component of innovation in the sectoral section is analysed on the example of grain production and pig farming. The scheme of complex innovative support of enterprise capital is offered. The information component of innovation is detailed. It is recommended to use the information component in full, taking into account the sector specificity of agrarian enterprises.
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Satyanarayana, Kanikaram, and Sadhana Srivastava. "Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) – A Strategic Option for India." Open AIDS Journal 4, no. 1 (January 19, 2010): 41–53. http://dx.doi.org/10.2174/1874613601004020041.
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The current HIV/AIDS scenario in India is quite grim with an estimated 2.4 million people living with HIV/AIDS (PLHA) in 2008, just behind South Africa and Nigeria. The anti-retroviral drugs (ARVs) remain the main stay of global HIV/AIDS treatment. Over 30 ARVs (single and FDCs) available under six categories viz., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), Protease inhibitors, the new Fusion inhibitors, Entry inhibitors-CCR5 co-receptor antagonists and HIV integrase strand transfer inhibitors. The major originator companies for these ARVs are: Abbott, Boehringer Ingelheim (BI), Bristol-Myers Squibb (BMS), Gilead, GlaxoSmithKline (GSK), Merck, Pfizer, Roche, and Tibotec. Beginning with zidovidine in 1987, all the drugs are available in the developed countries. In India, about 30 ARVs are available as generics manufactured by Aurobindo, Hyderabad, Andhra Pradesh; Cipla Limited, Goa; Emcure Pharmaceuticals, Pune, Maharashtra; Hetero Drugs, Hyderabad, Andhra Pradesh; Macleods Pharmaceuticals, Daman; Matrix Laboratories, Nashik, Maharashtra; Ranbaxy, Sirmour, Himachal Pradesh; and Strides Arcolab, Bangalore, Karnataka. The National AIDS Control Organization (NACO) set up in 1992 by the Govt. of India provides free ARVs to HIV positive patients in India since 2004. The drugs available in India include both single drugs and FDCs covering both first line and second line ARVs. Even while there are claims of stabilization of the disease load, there is still huge gap of those who require ARVs as only about 150,000 PLHA receive the ARVs from the Govt. and other sources. Access to ARVs therefore is still a cause of serious concern ever since India became fully Trade Related Aspects of Intellectual Property Rights (TRIPS)-complaint in 2005. Therefore, the Indian pharmaceutical companies cannot make generics for those for drugs introduced post-2005 due to product patent regime. Other concerns include heat stable, other better formulations and second line ARVs for adults and more drugs and formulations for paediatric groups, that are still to be widely available in India and other developing countries. To examine whether strong intellectual property (IP) protection systems are to be considered important barriers for the limited or lack of access to ARVs, we studied the patent profile of the ARVs of the originator companies within and outside India. We could record 93 patents in the United States Patent & Trademark Office (USPTO). The originator companies have been also aggressively filing and enforcing patents in India. There have been a few efforts by companies like Gilead and GSK to grant licenses to generic manufacturers in developing countries, ostensibly to promote access to ARVs through lower (two-tier) pricing. These steps are considered as too little and too late. There is an urgent need to look for alternative strategies to promote access to ARVs both linked to and independent of IPRs. Patent pooling as a viable strategy mooted by the UNITAID should be seriously explored to promote access to ARVs. India is ideally suited for trying out the patent pool strategy as most of the global requirement of affordable ARV drugs for HIV/AIDS treatment is sourced from Indian generic companies.
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Murti, Endang, and Zulin Nurchayati. "PENGEMBANGAN USAHA ANEKA KERIPIK MELALUI ONE VILLAGE ONE PRODUCT DI KECAMATAN KENDAL KABUPATEAN NGAWI PROVINSI JAWA TIMUR." Jurnal Terapan Abdimas 4, no. 1 (January 31, 2019): 83. http://dx.doi.org/10.25273/jta.v4i1.3813.
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<p>Abstract. Business Group Aneka Keripik Durian Karanggupito Village and Business Group Aneka Keripik Mawar Karangrejo Village, Kendal Kabupatean District Ngawi East Java Province. Production aspect of various chips produced need quality improvement, thickness, less crisp, less tasting seasoning,<br />dull label less attractive, product produced not durable food. It is necessary to transfer the knowledge of small business management extension and skill in the form of training of various varieties of flavor chips, as well as durable kripik quality, PIRT license, trademark is expected to be a special food or superior product of village of OVOP-based community product business in relation to community economic empowerment through: (a) socialization and motivation of OVOP-based product business mapping, (b) counseling and training on the quality of economic empowerment of villagers; (c) training of citizens' business products with economic empowerment of villagers. Economic empowerment based on OVOP approach is in line with One Village One Village Excellence Product Policy from East Java Provincial <br />Government through Community and Village Empowerment Office in the application, development and utilization of appropriate technology. In line with the Strategic Plan of Universitas Merdeka Madiun. The method of implementation in this program is counseling, instagram production skills training to market the product, and mentoring of production and marketing activities. With the realization of entrepreneurship training and understanding of social problems is expected to create jobs can make<br />social changes, especially the field of welfare and education. <br />Key Word : Empowerment, Economics, OVOP (one village one product).</p><p> </p><p>Abstrak. Kelompok Usaha Aneka Keripik Durian Desa Karanggupito dan KelompokUsaha Aneka Keripik Mawar Desa Karangrejo, Kecamatan Kendal Kabupatean Ngawi Provinsi Jawa Timur. Aspek produksi aneka keripik dihasilkan perlu peningkatan kualitas, terasa tebal, kurang renyah, bumbu kurang terasa, label kusam kurang menarik, produk dihasilkan bukan makanan tahan lama. Perlu transfer <br />knowledge penyuluhan manajemen usaha kecil dan pemberian skill berupa pelatihan pengolahan aneka<br />kripik varian rasa, serta kualitas kripik tahan lama, ijin PIRT, merek dagang diharapkan akan menjadi makanan khas atau produk unggulan desa produk usaha warga berbasis OVOP dalam kaitan pemberdayaan ekonomi masyarakat melalui: (a) sosialisasi dan motivasi pemetaan produk usaha warga<br />desa berbasis OVOP, (b) penyuluhan dan pelatihan kualitas pemberdayaan ekonomi warga desa, (c) pelatihan produk usaha warga dalam dengan pemberdayaan ekonomi warga desa. Pemberdayaan ekonomi berbasis pendekatan OVOP sejalan dengan Kebijakan Satu Desa Satu Produk Unggulan dari Pemerintahan Provinsi Jawa Timur melalui Dinas Pemberdayaan Masyarakat dan Desa dalam penerapan,<br />pengembangan dan pemanfaatan teknologi tepat guna. Sejalan dengan Renstra Universitas Merdeka Madiun. Metode pelaksanaan dalam program ini adalah penyuluhan, pelatihan ketrampilan pembuatan instagram untuk memasarkan produk, dan pendampingan aktivitas produksi dan pemasaran. Dengan terwujudnya pelatihan kewirausahaan dan pemahaman terhadap permasalahan sosial diharapkan dapat menciptakan lapangan pekerjaan dapat melakukan perubahan sosial terutama bidang kesejahteraan dan<br />pendidikan.<br />Katakunci : Pemberdayaan, Ekonomi, OVOP (one village one product).</p>
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Gaitán, Manuel Guerrero. "Licensing as a Central Structure of Technology Transfer Agreements – Joint Venture and Franchising Agreements." GRUR International 70, no. 5 (April 14, 2021): 427–39. http://dx.doi.org/10.1093/grurint/ikab032.
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Abstract R&D is one of the most important sources of knowledge and economic growth worldwide, and technology transfer is the principal means to access this knowledge. Nevertheless, market imperfections, externalities, and abusive behaviors have been used by some jurisdictions to justify the enactment of regulations on different contractual categories frequently used to implement this transfer of technology. According to the UNCTAD 2001 report, technology transfer agreements encompass an array of agreements differentiated by their subject matter. Such contracts cover, amongst other things, industrial property, know-how, and technology expertise.1 Most of the doctrine considers technology transfer agreements as an autonomous contractual category due to their standard features,2 such as their bilateral character, the reciprocal rights and obligations between the parties, and the presence of intellectual property rights.3 Thus, the agreements that belong to this category are often determined by the existence of intellectual property rights and know-how. These rights mainly protect useful knowledge that can be exploited in the market by its legal owner or the person who is authorized to do so. The exploitation of intangible assets is carried out using different sorts of contracts, frequently not regulated by law or other statutes and sometimes with a high degree of complexity, depending on the relevant technical matter and the parties’ activities. However, nowadays, despite the lack of specific regulation for most of these types of agreements, they are frequently used in the market and are indeed the licensing agreement that is most used and one of the few that are regulated in some jurisdictions.4 In the same sense, it is essential to highlight the presence of other contracts; for example, it is possible to find features of a trademark license, the sale of products, distribution, or even agency in a franchise agreement. This presence occasionally leads to difficulties in the construction of the parties’ will when there is silence or poor wording on the obligations to be performed. Concerning the construction of the contract, there are different forms that a technology transfer agreement may assume. In this regard, we must point out that the lack of legal classification5 means that it is necessary to use various sources, such as case law, arbitration awards, decisions of administrative bodies, and of course doctrine to carry out a complete analysis of these contracts. For the purpose of this study, a technology transfer agreement is to be considered as the transaction that allows a party to access a technology owned by the other party in exchange for consideration. This article’s main objective is to show how technology transfer occurs through licensing agreements in other complex contracts like joint ventures and franchising agreements. In order to illustrate this transfer of technology, we will throughout this article use statutes and case law of the European Union, the United States, and the Andean Community (CAN). The aim is to present, initially, the scope of the expression technology transfer; we will then examine how these three legal categories work, the relationship between these complex contracts and licensing, and finally, the importance of using the structure of licensing in joint ventures and franchising agreements adequately.
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Pincus, T., and N. Steen Krogh. "FRI0587 A NEW APPROACH TO EARLY DETECTION OF ADVERSE EVENTS OF HIGH-RISK MEDICATIONS USING A STRUCTURED, STANDARD, PROTOCOL DRIVEN WEEKLY REMOTE ELECTRONIC MDHAQ 60-SYMPTOM CHECKLIST." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 898–99. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4942.
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Background:A multidimensional health assessment questionnaire (MDHAQ) includes RAPID3, which distinguishes active from control treatments in rheumatoid arthritis clinical trials, and documents change comparably to disease-specific indices in all diseases studied. The MDHAQ also includes a standard, structured 60-symptom checklist, to recognize comorbidities, provide a review of systems, and serve on a fibromyalgia assessment screening tool (FAST3) as a clue to identify patients with fibromyalgia. A new MDHAQ application is to recognize adverse events to high-risk medications on a standard, structured, protocol-driven MDHAQ 60-symptom checklist. A structured list, rather than a “subjective” narrative medical history, is needed as many adverse events are common symptoms, e.g., headache, fatigue; prior negative data facilitates recognition of a new symptom as a possible adverse event. Similar strategies have been reported in oncology, pulmonology and other specialties, but not in rheumatology.Objectives:To use a remote electronic MDHAQ, completed weekly at home, to recognize RAPID3 clinical status changes and adverse events on the 60-symptom checklist, for early detection of medication adverse events.Methods:All patients with all diagnoses complete an MDHAQ at all visits in routine care at one rheumatology site. An electronic flowsheet (Table) is used to monitor 0-30 RAPID3, its components, and report of specific symptoms on the 60-symptom checklist, which appears required to document earlier absence of a common symptom and signal that a common symptom may be an adverse event. Results are depicted for an individual patient with pulmonary fibrosis, seen because of a positive rheumatoid factor.Results:A flowsheet of a pulmonary fibrosis patient over 2018 indicates initial RAPID3 of 14/30 and 10 symptoms at first visit of 19 Jan (Flowsheet). Treatment with low-dose methotrexate (MTX) and prednisone (PRED) led to substantial improvement over 6 months - RAPID3 3.5 and 6 symptoms on 2 Aug. On 15 Aug, MTX and PRED were discontinued by another physician, who prescribed pirfenidone. The patient telephoned on 24 Sep indicating distress. A home-completed remote MDHAQ indicated RAPID3 of 19.5 and 15 symptoms - 7 not reported on 2 Aug were among 16 listed pirfenidone adverse events. Discontinuation of pirfenidone and resumption of PRED and MTX with weekly remote electronic MDHAQ monitoring documented improvement of RAPID3 to 4.2 and 6 symptoms, including resolution of pirfenidone-specific symptoms, on 24 Dec (Flowsheet).Conclusion:Weekly remote electronic MHDAQ monitoring after initiation of a high-risk medication to monitor treatment responses and adverse events may provide a cost-effective approach to reduce morbidity and mortality of adverse events, involving about 10 minutes weekly (2 hours over 12 weeks) of patient time.78-year-old man monitored over 2018–all data from self-report on MDHAQ –pirfenidone highlighted (many entries deleted for space considerations)Date19Jan201825Jan20182Aug201815-29Aug201824Sep201826Sep20184Oct20189Oct20189Nov201825Nov201828Dec2018Site of MDHAQClinicClinicClinicNoneHomeHomeHomeHomeHomeHomeHomeRAPID3 (0-30)*14.010.23.5?19.510.26.76.54.86.04.2Prednisone mg/dayB 40↓20↓6D/C 0R 10555555Methotrexate mg/w20D/C 00000R 101010pirfenidoneB3-9/d9/dD/C003/DD/C0#Symptoms (0-60)*105615151313686Weight loss++++++Feeling sickly+Unusual fatigue+++++++Loss of appetite++++++Stuffy nose+++++++++Dry mouth+++++++++Problems with smell/taste+++++Cough++++++++++Dyspnea++++++++++Heartburn/gas+++++Joint pain+++++Back pain++Sleep problems++*Actual total - a few less relevant symptoms deleted for abstract requirementsTable 1.RF diagnostic performance in rheumatic diseasesGroupnIsotype**Cut-offUR/mlSignificanceAUC (95% CI)Sensitivity %Specificity %Youden IndexSensitivity %Manufacturercut-off +Specificity %Manufacturercut-off +RA22IgM135.30.060.722(0.604 to 0.839)60%85.20.4568.255.5Psa44IgA47.20.0740.698(0.553 to 0.842)54.581.80.3554.577.3ASP44IgA39.50.0800.668(0.511 to 0.826)54.588.60.4354.979.5SS44IgM180.60.0880.535(0.088 to 0.708)54.574.40.2868.29.3Healthy44IgM16.30.0460.896(0.806 to 0.986)77.388.90.6668.297.8SLE41IgA42.60.0730.701(0.557 to 0.845)54.585.30.3954.573.5FBM35IgM68.60.0710.752(0.612 to 0.892)63.682.80.4668.251.7OA38IgM48.00.0530.873(0.770 to 0.976)63.6960.5968.288PG20IgM117.00.0760.758(0.609 to 0.908)59.189.50.4968.263.2Total332** The isotype with the best AUC for each clinical scenario. + Manufacturer cut-off value: 20UR/mlDisclosure of Interests:Theodore Pincus Shareholder of:Dr. Pincus holds a copyright and trademark on MDHAQ and RAPID3 for which he receives royalties and license fees from profit-making organizations, all of which are used to support further development of quantitative clinical measures for patients and health professionals., Niels Steen Krogh: None declared
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Schroeder, K., S. Abu Mehsen, I. Castrejon, and T. Pincus. "FRI0517 POSSIBLE EARLY DETECTION OF ADVERSE EVENTS USING A STRUCTURED, STANDARD, 60-SYMPTOM CHECKLIST ON A MULTIDIMENSIONAL HEALTH ASSESSMENT QUESTIONNAIRE (MDHAQ)." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 857.2–858. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4771.
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Background:Adverse events of medications are reported to account for 5% of hospital admissions in the USA, including 10% in the elderly, despite extensive warnings to patients by health professionals and pharmacies concerning the problem. Some adverse events are relatively obvious, such as a severe rash or severely abnormal laboratory test. However, many adverse events are common symptoms, such as headache or fatigue, which may not necessarily be recognized as adverse events, particularly in elderly patients with many comorbidities. In clinical trials and other clinical research, a structured, standard, protocol-driven symptom checklist is recorded according to the “scientific method.” In routine care, by contrast, recognition and recording of adverse events is elicited by health professionals at patient encounters or contact initiated by patients between visits, as “subjective” medical history information, which may be highly variable. Use of a standard symptom checklist on an electronic patient questionnaire has been reported in oncology, pulmonology and other specialties, but not in rheumatology. A multidimensional health assessment questionnaire (MDHAQ) includes a standard 60-symptom checklist, to recognize comorbidities, provide a review of systems, and serve on a fibromyalgia assessment screening tool (FAST3) as a clue to identify patients with fibromyalgia. The MDHAQ 60–symptom checklist can identify new symptoms after initiation of a medication which may be adverse events.Objectives:To analyze an MDHAQ 60-symptom checklist as a cost-effective approach to recognize medication-associated adverse events.Methods:All patients at one site complete an MDHAQ at each visit, which includes a standard, structured 60-symptom checklist, in addition to RAPID3 (routine assessment of patient index data) and FAST3. Paper MDHAQs from routine care are scanned into an Epic electronic medical record (EMR) and copied into a data repository for retrospective analyses. A list of common adverse events of many specific DMARDs (disease-modifying antirheumatic drugs) and biological agents used to treat rheumatoid arthritis (RA) was compiled from websites of the FDA, pharmaceutical companies, and Up-to-date.® Most listed symptoms are found on the structured MDHAQ 60-symptom checklist. A retrospective review of scanned MDHAQs at the first visit was conducted to recognize the presence or absence of self-reported symptoms which were listed as common adverse events for specific DMARDs on the MDHAQ 60-symptom checklist, using simple descriptive statistics. Only methotrexate (Mtx) is presented here due to space limitations.Results:All symptoms listed as adverse events of specific DMARDs were reported at higher frequencies in 379 DMARD-treated RA patients or 153 Mtx-treated patients, compared to 149 DMARD-naïve patients (Table). More than 30% of DMARD-treated patients reported headache and/or unusual fatigue, 27% anxiety; 10-20% cough, dizziness, hair loss, nausea, skin rash or hives, stomach pain or cramps, eye problems, and/or weight loss; and 5-10% diarrhea, fever, and/or mouth sores (Table). Similar proportions were seen for Mtx-treated patients, although anxiety and cough were not listed as specific adverse events.Conclusion:The MDHAQ symptom checklist may prove valuable to detect adverse events of high-risk medications, including on an electronic MDHAQ, which could be completed at home for 12 weeks after initiation of a new medication as a cost-effective approach for early detection of adverse events.Symptom listed on MDHAQ/MEDI60DMARD naïveN=149(28%)DMARD treatedN=379(72%)MethotrexateN=153(29%)Headache28%36%36%Unusual fatigue31%33%34%Anxiety23%27%Cough16%18%Dizziness14%18%20%Hair loss10%17%19%Nausea11%13%18%Skin rash or hives11%14%13%Stomach pain/cramps9%16%15%Eye problems9%13%14%Anorexia/weight loss10%16%17%Diarrhea5%9%8%Fever5%8%7%Mouth sores3%7%8%Disclosure of Interests:Kyle Schroeder: None declared, Sara Abu Mehsen: None declared, Isabel Castrejon: None declared, Theodore Pincus Shareholder of:Dr. Pincus holds a copyright and trademark on MDHAQ and RAPID3 for which he receives royalties and license fees from profit-making organizations, all of which are used to support further development of quantitative clinical measures for patients and health professionals.
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Mullins, Eric S., Christine M. Knoll, Amy L. Dunn, Werner Engl, Marlies Sharkhawy, and Brigitt E. Abbuehl. "Pegylated Full-Length Recombinant Factor VIII with Extended Half-Life in Previously Treated Pediatric Patients with Hemophilia Α: Efficacy of Prophylaxis and Treatment By Time (of Day/of Week) of Occurrence of Bleeding." Blood 128, no. 22 (December 2, 2016): 1409. http://dx.doi.org/10.1182/blood.v128.22.1409.1409.
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Abstract Introduction: Hemophilia A (HA) is an X linked recessive bleeding disorder characterized by frequent bleeding predominantly in joints. To avoid the sequelae of hemarthroses (e.g., target joints and arthropathy), timing of factor VIII (FVIII) infusions to cover periods of physical activity and adherence to a prophylactic schedule are particularly important in children with HA. BAX 8551, a polyethylene glycol (peg)ylated, extended half-life, full-length, recombinant FVIII built on ADVATE2, was developed to reduce infusion frequency while maintaining or improving therapeutic efficacy. Methods: Efficacy of twice-weekly prophylaxis with BAX 855 was evaluated in a phase 3, prospective, uncontrolled, multicenter study in pediatric previously treated patients with severe HA (FVIII level <1%) without inhibitors (<0.6 BU using the Nijmegen modification). Annualized bleeding rates (ABRs) and efficacy of bleed treatment were analyzed by time of day (morning [04:00 - 11:59], afternoon [12:00 - 17:59], evening [18:00 - 03:59]) and period of the week (weekday [Monday - Friday], weekend [Saturday, Sunday]). The study was performed in accordance with the principles of the Declaration of Helsinki of the World Medical Association. Results: Sixty-six patients, 32 aged <6 and 34 aged 6 to <12 years, were treated with a mean (SD) prophylactic BAX 855 dose of 51.1 (5.5) IU/kg at a frequency of 1.8 (0.2) infusions per week for 48.5 (7.7) exposure days. ABRs were highest in the evening with point estimates (95% CIs) of the mean of 1.0 (0.7 - 1.5) compared to 0.6 (0.4 - 1.0) in the afternoon and 0.5 (0.3 - 1.1) in the morning. On weekdays, the point estimate (95% CI) of the mean ABR was 2.4 (1.7 - 3.5), on weekends it was 0.9 (0.6 - 1.2). For all periods assessed except for mornings, ABRs were higher in the older than in the younger cohort (Table 1). Seventy minor or moderate bleeding events in 34/66 (51.5%) patients were treated with a mean (SD) dose of 57.9 (31.0) IU/kg of BAX 855. Most treated bleeds occurred in the evening (34.3%; 24/70), fewer in the afternoon (22.9%; 16/70) and in the morning (14.3%; 10/70). The proportion of moderate bleeds increased during the day from 20.0% (2/10) in the morning to 31.3% (5/16) in the afternoon and 70.8% (17/24) in the evening. For 28.6% (20/70) of treated bleeds, the time of day of occurrence was unknown. The mean interval between the preceding prophylactic infusion and the bleeding event was similar for all times of day, ranging from 51.0 h to 54.6 h (median 51.4 h to 57.8 h). On weekends, the mean interval between prophylactic dose and bleeding event was lower (38.8 h; median 35.7 h) than on weekdays (54.6 h; median 52.9 h), suggesting that the time of infusion was chosen to cover for weekend activities. Bleeding severity was similar on weekdays and on weekends. Efficacy of bleed treatment with BAX 855 was rated excellent or good for ≥85% of bleeds and ≥85% were treated with 1 or 2 infusions, irrespective of the time of day/period of the week the bleeds occurred. Conclusions: In this study in pediatric patients with severe HA, bleeding was observed more frequently in the evening than during other times of day and more frequently on weekdays than on weekends. BAX 855 was shown to be effective for the prevention and treatment of bleeding in this patient population. 1BAX 855 (Baxalta US Inc., now part of Shire) is licensed in the US and Japan under the trade name ADYNOVATE. 2ADVATE is a trademark of Baxalta US Inc., now part of Shire. Disclosures Mullins: Baxalta (now part of Shire): Honoraria; US WorldMeds: Membership on an entity's Board of Directors or advisory committees. Dunn:Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Baxalta (now part of Shire): Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Biogen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; CSL Behring: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Research Funding; Kedrion: Research Funding; NovoNordisk: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Octapharma: Research Funding. Engl:Shire: Employment, Equity Ownership. Sharkhawy:Baxalta (now part of Shire): Employment. Abbuehl:Baxalta (now part of Shire): Employment.
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Masset, Heleen, Masoud Zamani Esteki, Eftychia Dimitriadou, Jos Dreesen, Sophie Debrock, Josien Derhaag, Kasper Derks, et al. "Multi-centre evaluation of a comprehensive preimplantation genetic test through haplotyping-by-sequencing." Human Reproduction 34, no. 8 (July 26, 2019): 1608–19. http://dx.doi.org/10.1093/humrep/dez106.
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Abstract STUDY QUESTION Can reduced representation genome sequencing offer an alternative to single nucleotide polymorphism (SNP) arrays as a generic and genome-wide approach for comprehensive preimplantation genetic testing for monogenic disorders (PGT-M), aneuploidy (PGT-A) and structural rearrangements (PGT-SR) in human embryo biopsy samples? SUMMARY ANSWER Reduced representation genome sequencing, with OnePGT, offers a generic, next-generation sequencing-based approach for automated haplotyping and copy-number assessment, both combined or independently, in human single blastomere and trophectoderm samples. WHAT IS KNOWN ALREADY Genome-wide haplotyping strategies, such as karyomapping and haplarithmisis, have paved the way for comprehensive PGT, i.e. leveraging PGT-M, PGT-A and PGT-SR in a single workflow. These methods are based upon SNP array technology. STUDY DESIGN, SIZE, DURATION This multi-centre verification study evaluated the concordance of PGT results for a total of 225 embryos, including 189 originally tested for a monogenic disorder and 36 tested for a translocation. Concordance for whole chromosome aneuploidies was also evaluated where whole genome copy-number reference data were available. Data analysts were kept blind to the results from the reference PGT method. PARTICIPANTS/MATERIALS, SETTING, METHODS Leftover blastomere/trophectoderm whole genome amplified (WGA) material was used, or secondary trophectoderm biopsies were WGA. A reduced representation library from WGA DNA together with bulk DNA from phasing references was processed across two study sites with the Agilent OnePGT solution. Libraries were sequenced on an Illumina NextSeq500 system, and data were analysed with Agilent Alissa OnePGT software. The embedded PGT-M pipeline utilises the principles of haplarithmisis to deduce haplotype inheritance whereas both the PGT-A and PGT-SR pipelines are based upon read-count analysis in order to evaluate embryonic ploidy. Concordance analysis was performed for both analysis strategies against the reference PGT method. MAIN RESULTS AND THE ROLE OF CHANCE PGT-M analysis was performed on 189 samples. For nine samples, the data quality was too poor to analyse further, and for 20 samples, no result could be obtained mainly due to biological limitations of the haplotyping approach, such as co-localisation of meiotic crossover events and nullisomy for the chromosome of interest. For the remaining 160 samples, 100% concordance was obtained between OnePGT and the reference PGT-M method. Equally for PGT-SR, 100% concordance for all 36 embryos tested was demonstrated. Moreover, with embryos originally analysed for PGT-M or PGT-SR for which genome-wide copy-number reference data were available, 100% concordance was shown for whole chromosome copy-number calls (PGT-A). LIMITATIONS, REASONS FOR CAUTION Inherent to haplotyping methodologies, processing of additional family members is still required. Biological limitations caused inconclusive results in 10% of cases. WIDER IMPLICATIONS OF THE FINDINGS Employment of OnePGT for PGT-M, PGT-SR, PGT-A or combined as comprehensive PGT offers a scalable platform, which is inherently generic and thereby, eliminates the need for family-specific design and optimisation. It can be considered as both an improvement and complement to the current methodologies for PGT. STUDY FUNDING/COMPETING INTEREST(S) Agilent Technologies, the KU Leuven (C1/018 to J.R.V. and T.V.) and the Horizon 2020 WIDENLIFE (692065 to J.R.V. and T.V). H.M. is supported by the Research Foundation Flanders (FWO, 11A7119N). M.Z.E, J.R.V. and T.V. are co-inventors on patent applications: ZL910050-PCT/EP2011/060211- WO/2011/157846 ‘Methods for haplotyping single cells’ and ZL913096-PCT/EP2014/068315 ‘Haplotyping and copy-number typing using polymorphic variant allelic frequencies’. T.V. and J.R.V. are co-inventors on patent application: ZL912076-PCT/EP2013/070858 ‘High-throughput genotyping by sequencing’. Haplarithmisis (‘Haplotyping and copy-number typing using polymorphic variant allelic frequencies’) has been licensed to Agilent Technologies. The following patents are pending for OnePGT: US2016275239, AU2014345516, CA2928013, CN105874081, EP3066213 and WO2015067796. OnePGT is a registered trademark. D.L., J.T. and R.L.R. report personal fees during the conduct of the study and outside the submitted work from Agilent Technologies. S.H. and K.O.F. report personal fees and other during the conduct of the study and outside the submitted work from Agilent Technologies. J.A. reports personal fees and other during the conduct of the study from Agilent Technologies and personal fees from Agilent Technologies and UZ Leuven outside the submitted work. B.D. reports grants from IWT/VLAIO, personal fees during the conduct of the study from Agilent Technologies and personal fees and other outside the submitted work from Agilent Technologies. In addition, B.D. has a patent 20160275239 - Genetic Analysis Method pending. The remaining authors have no conflicts of interest.
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Schroeder, K., T. Pincus, and M. Bergman. "AB1194 STRIKING DIFFERENCES IN THE COURSE OF OSTEOARTHRITIS (OA) COMPARED TO RHEUMATOID ARTHRITIS (RA) OVER THE FIRST 24 MONTHS OF RHEUMATOLOGY CARE AT ONE PRIVATE PRACTICE SETTING." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1887.2–1888. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3840.
Full textAbstract:
Background:Recent reports indicate that disease burden in osteoarthritis (OA) is similar to or greater than in rheumatoid arthritis (RA) when an identical measure is used to assess patients with either disease, generally an MDHAQ/RAPID3 (multidimensional health assessment questionnaire/routine assessment of patient index data). The data suggest that a traditional view that RA is more severe than OA no longer is valid at this time. One concern is that similar disease burdens in OA vs RA may result entirely from superior treatments for RA, and RA may be considerably more severe than OA at initial presentation.Objectives:To analyze MDHAQ disease burden in patients with OA vs RA at initial visit and at 24-month follow-up in routine care at a single solo-rheumatologist private practice setting.Methods:All patients at this setting complete an MDHAQ at each visit in the waiting area, prior to seeing the rheumatologist. The MDHAQ includes three 0-10 scores for physical function, pain visual numeric scale (VNS), and patient global VNS, which may be compiled into a 0–30 RAPID3, as well as a 0-10 fatigue VNS, and 0-16 rheumatoid arthritis disease activity index (RADAI) self-report painful joint count. Mean MDHAQ scores were analyzed for all 73 OA and 116 RA patients seen for an initial visit between 2011 and 2017. Mean scores at initial and 24-month visits were compared for all 25 OA and 63 RA patients seen at 24 month (21-27 month) follow-up visits, using paired t tests.Results:Mean MDHAQ scores at first visit were similar for all 73 OA and 116 RA patients, and also for 25 OA and 63 RA patients who were also seen 24 months later, e.g., mean RAPID3 was 12.0-14.2. However, mean changes over 2 years were strikingly different in OA versus RA patients (Table). Almost all mean scores in OA were somewhat higher, while all mean scores in RA were clinically and statistically significantly improved at 24 months, e.g., mean RAPID3 worsened from 13.0 to 15.2 (+2.2 units, 17%) in OA patients, compared to improvement from 12.5 to 8.2 (-4.3 units, -34%) in RA patients. The smallest mean change in RA patients involved the joint count (7.7 to 6.1, -21%) (Table), suggesting possible control of inflammation, but continued damage to specific joints. An important limitation is that the data do not include follow-up on patients not seen over the 24 month “window,” because of substantially better or poorer status, joint surgery, or other reasons, although the data present an accurate characterization of one rheumatology practice setting.Mean values of patient MDHAQ scores in patients with OA or RA at first visit and 24-month follow-upMDHAQ score:OA first visit of those seen at 24 months(n=25)OA 24- month visit (n=25)% change, over 24 monthsRA first visit of those seen at 24 months(n=63)RA 24- month visit (n=63)% change, over 24 monthsRAPID313.015.2+2.2, +17%12.58.2-4.3, -34%Function0.810.77-0.04, -5%0.710.50-0.21, -29%Pain5.26.4+1.2, +23%5.13.2-1.9, -37%Patient global5.15.9+0.8, +16%5.13.3-1.8, -35%Fatigue4.14.4+0.3, +7%4.83.5-1.3, -27%Pt joint count7.57.8+0.3, +4%7.76.1-1.6, -21%Abbreviations: MDHAQ=multidimensional health assessment questionnaire, OA=osteoarthritis, RA=rheumatoid arthritis, RAPID3=routine assessment of patient index data.In change data, negative numbers indicate improvement, positive numbers indicate worsening.Conclusion:Mean MDHAQ/RAPID3 scores were similar in RA or OA at the initial visit. Over 24 months, scores worsened slightly in OA and improved considerably in RA, resulting in considerably poorer status in OA versus RA, likely reflecting superior treatments for RA vs OA. At an individual level, patients with primary OA may have better or poorer status than patients with primary RA. Nonetheless, at a group level, the severity of disease burden in OA appears similar to RA, and becomes greater over the next 24 months, likely as a result of better treatments. The severity of OA is underrated, suggesting a need for increased resources for research toward better treatments for OA.Disclosure of Interests:Kyle Schroeder: None declared, Theodore Pincus Shareholder of:Dr. Pincus holds a copyright and trademark on MDHAQ and RAPID3 for which he receives royalties and license fees from profit-making organizations, all of which are used to support further development of quantitative clinical measures for patients and health professionals., Martin Bergman Shareholder of: Johnson & Johnson – stockholder, Consultant of: AbbVie, BMS, Celgene Corporation, Genentech, Janssen, Merck, Novartis, Pfizer, Sanofi – consultant, Speakers bureau: AbbVie, Celgene Corporation, Novartis, Pfizer, Sanofi – speakers bureau